Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

Sponsor

Rana Elbanna (Other)

Overall Status

Recruiting

CT.gov ID

NCT05785117

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

34.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Participants were randomly assigned to two groups prior to their second visit: the Vagus nerve stimulation group (VNS) and the circuit training program. The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined. Vagus nerve stimulation group(VNS) Patients rested on their sides in a sitting position. Following regular disinfection of the stimulation locations, ear clips were placed in the ear region (auricular concha) at the stimulation site. The training regimen included ten different forms of resistance and aerobic exercises.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Device: Vagal Stimulation Other: Circuit training program	N/A

Detailed Description

Vagus nerve stimulation group Group:

Each participant signed a consent form after receiving a detailed explanation about the procedure.
Patients rested on their sides in a sitting position.
Disinfection of the stimulation locations.
Ear clips were placed in the ear region (auricular concha) at the stimulation site.
Emotional eating was assessed by Emotional Eating Scale. 5. Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).
Cortisol was assessed in lab. 7. After one month all the assessment procedure will be repeated again.

Circuit training group Group:

Each participant will signed a consent form after receiving a detailed explanation about the procedure.
The training regimen included ten different forms of resistance and aerobic exercises.
Emotional eating was assessed by Emotional Eating Scale.
Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).

5 Cortisol was assessed in lab. 6. After one month all the assessment procedure will be repeated again.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Non-invasive Auricular Vagal Nerve Stimulation Versus Circuit Weight Training on Nutritional Modulation in Patient With Metabolic Syndrome

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vagus nerve stimulation group Vagus nerve stimulation group	Device: Vagal Stimulation ear clips were placed in the ear region (auricular concha) at the stimulation site. The following stimulation settings were used: 1) density wave set to 20 Hz with a wave width of less than 1 ms; 2) intensity tuned to the patient's tolerance (4-6 mA)
Experimental: Circuit weight training group Group Circuit weight training group Group	Other: Circuit training program The training regimen included ten different forms of resistance and aerobic exercise that were done three times a week for four weeks. The resistance training program included push-ups, squats, crunches, lunges, and a superman exercise program that included light jumping, jogging on the spot, foot stomping, steps, and jumping jacks

Arm

Intervention/Treatment

Experimental: Vagus nerve stimulation group

Vagus nerve stimulation group

Device: Vagal Stimulation

ear clips were placed in the ear region (auricular concha) at the stimulation site. The following stimulation settings were used: 1) density wave set to 20 Hz with a wave width of less than 1 ms; 2) intensity tuned to the patient's tolerance (4-6 mA)

Experimental: Circuit weight training group Group

Circuit weight training group Group

Other: Circuit training program

The training regimen included ten different forms of resistance and aerobic exercise that were done three times a week for four weeks. The resistance training program included push-ups, squats, crunches, lunges, and a superman exercise program that included light jumping, jogging on the spot, foot stomping, steps, and jumping jacks

Outcome Measures

Primary Outcome Measures

Emotional eating [4 weeks]
Emotional Eating was measured by a 15-item version of the Emotional Eating Scale. The scale required responses from 0 (no desire to eat) to 4 (an overwhelming urge to eat) based on "… the extent which the following feelings presently lead you to feel an urge to eat. A lower score indicated less of an urge to eat when the designated emotional state was present.
Patient satisfaction measures [4 weeks]
The Short Assessment of Patient Satisfaction (SAPS) is a seven-item scale that can be utilized to measure patient satisfaction with their treatment. The seven-item Short Assessment of Patient Satisfaction (SAPS), which is scored on a 5-point scale (0-4) SAPS has a continuous score range of 0 to 28. SAPS categorical responses include 0-10 very dissatisfied, 11-18 dissatisfied, 19-26 satisfied, and 27-28 very satisfied.
Cortisol level [4 weeks]
Participants use a disposable plastic straw to 'drool' saliva into the tube after collecting it in their mouths for a predetermined period of time (one minute) Saliva samples for cortisol measurement kept at room temperature until they are examined in a lab (4 to 6 hours)

Secondary Outcome Measures

Body weight [4 weeks]
After an eight-hour fast, body weight was taken between 7:00 and 10:00 am using a digital scale that was accurate to ±0.1 kg

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

having two or more than one of the following:

Type 2 diabetes Miletus
Hypertensive.
Abnormal Cholesterol or Triglyceride level.
BMI more than 30 kg/m
Waist circumference more than 94 cm.

Exclusion Criteria:

Vagotomy.
Diathermy.
Wallowing difficulties.
Dyspnea.
Cardiac arrhythmia.
Seizure.
Previous brain injury or surgery.
Dysautonomia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient clinic faculty of physical therapy at Cairo University	Giza		Egypt	12613

Sponsors and Collaborators

Rana Elbanna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rana Elbanna, lecturer at faculty of physical therapy at Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT05785117

Other Study ID Numbers:

Dr Rana Hesham

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Mar 27, 2023